An open label,3 way cross over study to analyse the drug interaction between colesevelam HCL and phenytoin in healthy human adult subjects when administered together and when administered with a time interval of 4 hours.
- Registration Number
- CTRI/2010/091/000235
- Lead Sponsor
- Daiichi Sankyo Pharma Development Daiichi Sankyo India Development
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
1. Male and female subjects, 18 to 45 years of age inclusive and with a Body Mass Index (BMI) of 18 to 30 kg/m2, inclusive
2. Females who are non-childbearing potential, must be
? Naturally postmenopausal (spontaneous cessation of menses) for at least 12 consecutive months prior to dosing with an Follicle Stimulating Hormone (FSH) level at screening of ≥ 40 mIU/L
? Surgical removal of both ovaries and/or uterus at least 6 months prior to dosing
3. Females who are of childbearing potential, must use an acceptable method of contraception for 2 weeks prior to the first dose and for 4 weeks following their last dose of the study or until their first normal menstrual period
(whichever is longer);
? Study-acceptable methods of birth control are: double-barrier methods,which include combination of any 2 of the following: diaphragm, condom, copper intrauterine device, sponge, or spermicide
? Females who are abstinent can be included, provided they agree to use a study-acceptable method of double barrier contraception if she becomes sexually active during the same timeframe specified above
? For female subjects, a partner?s use of condoms alone, partner?s vasectomy, or spermicide alone, are not study-acceptable methods of birth control but should be used in addition to female contraception for additional protection against conception
4. All females must have a negative serum pregnancy test at screening and within 24 hours before the phenytoin doses in periods I, II, III
5. Males should agree to use an acceptable method of contraception from the first dose of study drug until 90 days after the last dose. Males should refrain from
sperm donation from the first dose of study drug until 90 days after the last dose
6. Subjects must be in good health as determined by the medical history, physical examination, vital signs, electrocardiogram, blood chemistry, hematology, and
urinalysis performed at screening
7. Subjects must give written informed consent to participate in the study prior to screening. Consent will be documented by the subject's dated signature and
will be counter-signed and dated by an impartial witness, in case of illiterate subjects.
8. Subjects must be able to comply with the protocol and the assessments therein
1. History of drug abuse
2. History of alcohol addiction during the past two years
3. Current or recent use (within the last 3 months) of tobacco or other nicotine containing product
4. Subjects who have a history or presence of bowel obstruction (or who are at risk for bowel obstruction e.g. subjects with gastro paresis, other gastrointestinal motility disorders or history of major gastrointestinal surgery)
5. Subjects with dysphagia or swallowing disorders
6. Subjects with past history of and/or presence of hypertriglyceridemia-induced acute pancreatitis
7. Subjects with TG concentrations more than 500 mg/dL at screening
8. Subjects with past history of epilepsy
9. Hypersensitivity to phenytoin sodium ER, other hydantoins or colesevelam HCl
10. Any clinically significant medical history or current evidence of significant cardiac, hepatic, renal,pulmonary, endocrine, neurologic, infectious, gastrointestinal, hematologic, oncologic, or psychiatric disease, or any other medical condition that investigator considers may affect subject safety or the results or outcome of the study
11. Any major surgical procedure in the 30 days prior to dosing
12. Subjects who tested positive at screening for HIV, HBsAg or HCV
13. Subjects with laboratory results outside the normal range, if considered clinically significant by the investigator
14. Subjects with positive results on screening tests for drugs of abuse, cotinine and alcohol at screening or the pre-dose assessment
15. Subjects who need to take any concomitant medication during the course of the study, with the exception of acetaminophen (up to 2g/day)
16. Use of any prescription drug within 14 days of study initiation or any non prescription drug/supplement (including Over-The-Counter (OTC), topical medications or herbal supplements) within 14 days of study initiation or any anticipated need of non study drugs within the confinement period
17. Use of any drugs or substances known to be strong inducers or inhibitors of CYP enzymes within 28 days prior to the first dose. St-John?s Wort (hypericin) must be excluded for at least 28 days from the first dosing
18. Subjects who consumed or do not agree to abstain from grapefruit and grapefruit juice from 10 days before the first dose and throughout confinement
19. Male subjects who consume more than 28 units of alcohol per week and female subjects who consume more than 21 units of alcohol per week (one unit of alcohol equals 250 mL of beer, 100 mL or a medium glass of wine, or
25 mL of spirits) or those subjects who have a significant history of alcoholism within the last 2 years.
20. Participation in a clinical study within 90 days of dosing
21. Subjects who have received a transfusion or any blood products within 30 days prior to Period I, Day 1
22. Hemoglobin 12 g/dL at Screening
23. Blood donation or significant blood loss of 250 mL or more and plasma donation within 56 days prior to dosing, during the study or who is planning for blood donation 4 weeks after the last dose.
24. Female is pregnant (as based on test results) or is breast feeding
25. Subjects who, in the opinion of the investigator, should not participate in the study
26. Subjects who are employed by the CPU.
27. Subjects who have a familial relationship with another study participant.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method